RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE - II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

|1. |NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK |DR SANDEEP M, POST-GRADUATE IN|

| |LETTERS) |PAEDIATRICS, DEPARTMENT OF PAEDIATRICS, MYSORE MEDICAL |

| | |COLLEGE AND RESEARCH INSTITUTE, MYSORE - 570001 |

|2. |NAME OF THE INSTITUTION |MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE |

|3. |COURSE OF STUDY AND SUBJECT | M.D (PAEDIATRICS) |

|4. |DATE OF ADMISSION TO COURSE AND DATE OF | 28 APRIL 2011 |

| |COMMENCEMENT OF COURSE |31 MAY 2011 |

|5. |TITLE OF THE TOPIC |THYROID HORMONE STATUS, SERUM TOTAL PROTEIN, SERUM ALBUMIN LEVELS IN |

| | |CHILDREN WITH PROTEIN ENERGY MALNUTRITION |

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 Need for the Study:

Protein energy malnutrition is a nutritional deficiency resulting from either inadequate energy (calorie) or protein intake. The spectrum of protein energy malnutrition includes underweight children, kwashiorkor, marasmus, marasmic kwashiorkor. Marasmus is characterised by wasting of muscles and subcutaneous fat and is usually a result of severe restrictions in energy intake. Kwashiorkor is characterised by oedema, mental apathy, growth retardation and is usually the result of severe restrictions in protein intake1, 2.

The term marasmus is derived from the Greek word marasmos which means withering or wasting2.

The term kwashiorkor is taken from the Ga language of Ghana and means “the sickness of the weaning” or the disease that occurs when the child is displaced from the breast by another child. Dr. Cicely D Williams introduced the name into the international medical community 2, 3, 6. 

In 1959, Jelliffe introduced the term ‘Protein Calorie Malnutrition’ (PCM) as there was close association between the two poles of the syndrome namely, Kwashiorkor and Marasmus. The term PCM, was later rephrased as Protein Energy Malnutrition (PEM) in 19764.

In International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Version for 2010 PEM has been included in Chapter IV E40-E465.

According to estimates in the world today, there are about 146 million children suffering from various forms of PEM. It is estimated that PEM is the primary or associated cause of around half of nearly 11 million deaths in children under 5 years every year6.

PEM remains an important public health problem in India. National family health survey 3 (NFHS3) showed prevalence of underweight, stunting and wasting in children under 5 years in India to be 43%, 48%, 20% respectively7.The prevalence of underweight, stunting and wasting in Karnataka is 38%, 44%, and 18% respectively 8.

In PEM various endocrinal changes may be noted which includes elevation in Growth Hormone levels the degree of elevation was related to the degree of reduction in plasma albumin. Severe hypoglycemia can be seen terminally, but in general fasting glucose is in the low normal range accompanied by low fasting serum insulin levels. Normal to increased adrenocortical activity may be present in malnourished children9.

Manifestations of PEM include retarded growth rate and limited weight gain with delayed skeletal maturation. These effects may be mediated by alterations in hormonal and metabolic balance such as changes in thyroid hormone metabolism. Normally, 100% of circulating thyroxine (T4) and 20% of circulating triiodothyronine (T3) originate from the thyroid gland, majority of T3 is produced by 5'-deiodination of thyroxine, primarily by the liver and kidney. In energy and protein restriction, several aspects of thyroid hormone and iodine metabolism are affected. Serum proteins including thyroxine-binding globulin (TBG), thyroxine-binding pre-albumin (TBPA) and albumin are all reduced due to decreased protein intake and reduced hepatic biosynthesis. In acute PEM there is reduction in total T3, T4 secondary to reduced plasma proteins with maintained euthyroid state, in prolonged PEM there is overriding of adaptive mechanism leading to hypothyroidism. These changes play an important role in adaptive process of energy and protein metabolism in PEM, help in energy conservation when energy producing substrate is scarce, protects the child from early death due to low calorie reserve 9.

Several studies have showed that there is reduction in serum thyroxine (T4) and triiodothyronine (T3) levels in children with PEM, where as the thyroid stimulating hormone (TSH) levels remained within normal limits13, 16. Some of the studies have showed that there is reduction in serum T3, T4 levels in children with PEM, where as TSH is elevated in children with PEM as compared to healthy children 14, 18.

In children with PEM serum proteins, serum albumin will be low. Fall in serum albumin is seen only after about 3 weeks of malnutrition, various adaptations during this period are shift from extravascular pool to intravascular pool, decreased catabolism, decreased urine excretion of nitrogen. Total serum globulin will be in normal limits. Amino acid pool will be decreased to 50% of normal 2.

Several studies have shown that serum total protein and serum albumin levels are low in children with PEM as compared to healthy children 17, 18.

This study is undertaken to determine thyroid hormone status, serum total protein, serum albumin levels in children with Protein energy malnutrition.

6.2 Review of Literature:

1. In 1975 Ingenbleek Y et al in their study on 43 Senegalese children aged eighteen to thirty months found that there was a sharp fall in serum T3 concentration to 25-3% of normal mean value in PCM infants as compared to normal healthy controls, finding which suggests that impaired thyroxine (T4) monodeiodination in the liver was responsible for the fall in serum-T3 concentration rather than a reduction in the secretion of T3 by the thyroid. Serum TSH was within normal limits10.

2. In 1982 Farida Khatun UH et al in their study on Thyroid function in children with PEM made an observation that there was decrease in serum concentration of both T3 and T4, which may possibly be due to a deficiency of protein or due to a blockade in the incorporation of iodine into thyroid hormone at some stage after iodide transport into the gland11.

3. In 1983 Onuora et al in their study on thyroid status in 102 children with various degree of protein calorie malnutrition (PCM) noted that T3 was low in all cases of PCM. T4 was low in kwashiorkor, marasmic-kwashiorkor and they found that T3, T4 levels correlated with the levels of plasma proteins in the undernourished, marasmic and kwashiorkor states12.

4. In 1995 S Turkey et al in their study on 107 children aged 2 to 60 months in the malnutrition group found that Serum total thyroxine (TT4) and total triiodothyronine (TT3) were all reduced in the malnutrition group, decrease in TT3 was more significant in severe malnutrition than in mild malnutrition. Serum TSH levels in the malnutrition and control groups were similar. Results suggest that the children remained euthyroid and represent an adaptive response to protein energy malnutrition which enables the sick patient to conserve protein. Low levels of binding proteins, altered rate of total and free fractions and decreased peripheral conversion of T4 and T3 are considered to be responsible for such low levels of T3. Low levels of thyroid hormone binding proteins in malnutrition are thought to be due to decreased protein intake and reduced hepatic biosynthesis of these proteins in liver13.

5. In 1998 Orbak Z et al in their study on children suffering from malnutrition found that in the groups with marasmus and kwashiorkor the mean TT4, TT3 and free triiodothyronine (FT3) levels were significantly lower and TSH levels were significantly higher compared to controls. Free thyroxine (FT4) was not influenced by PEM14.

6. In 1999 B K Das et al in their study on 76 malnurished infants and children (cases) between the age of 6-48 months found that mean T3 and free T3 were low in all cases where as TSH and T4 were within normal limits. T3 and free T3 levels showed strong positive correlation with serum total protein and albumin levels. Normal TSH was due to intracellular monodeiodination of T4 to T3 at pituitary level and normal T4 was due to adaptive process15.

7. In 2001 Pankaj Abrol et al in their study on Thyroid Hormone Status in 80 PEM children in India found that T3, T4 were significantly low in PEM children as compared to normal controls and TSH levels were similar to controls16.

8. In 2005 Rahman M Z et al in their study on 30 children suffering from protein energy malnutrition of different grade made an observation that Serum total protein and albumin levels in grade-I grade-II and grade-III PEM were significantly lowers than controls. Serum albumin/globulin ratio (A/G) of grade-1 & grade-II PEM were high than that of control, but not significantly, but in grade-III PEM this values were significantly higher than that of control17.

9. In the year 2009 Sanjeev Kumar et al in their study on 60 children with malnutrition (cases) made an observation that there was significant correlation between severity of malnutrition and anthropometry, mean serum total protein and albumin levels were significantly lower in grade II and III cases. With progressive increase of severity of malnutrition the T3 level decreased significantly, mean serum T4 level also showed a significant fall in grade III PEM, serum TSH level progressively increased with increasing severity of malnutrition. Low plasma T3 levels was due to decreased peripheral conversion of T4 to T3 and attributed to impaired thyroid binding proteins like TBG, TBPA and Albumin18.

6.3 Objectives of study:

1. To estimate serum triiodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH) levels in children with Protein Energy Malnutrition (PEM) (cases) and control, there by evaluating the Thyroid hormone status in children with PEM.

2. To estimate serum total protein and serum albumin in children with PEM (cases) and control, there by evaluating serum total protein and serum albumin level in children with PEM.

6.4 Hypothesis:

1. Serum thyroxine (T4), serum triiodothyronine (T3) will be low in PEM group as compared to control.

2. Serum thyroid stimulating hormone (TSH) will be normal in both PEM group and control.

3. Serum total protein and serum albumin will be low in PEM group as compared to control.

7 MATERIAL AND METHODS:

7.1 Source of data: The proposed study is a hospital based case control study consisting of children aged between 1 to 5 years. They will be evaluated at Department of Paediatrics, Cheluvamba hospital, Mysore Medical College and Research Institute, Mysore during the term between January 2012 to December 2012.

7.2 Method of collection of Data:

Sample size: 250 children meeting the criteria will be included for the present study, case (PEM group) and control will contain equal number of children.

Type of study: Case control study

Sampling method: Simple Random Sampling

Inclusion criteria: Children with Protein energy malnutrition and without Protein energy malnutrition as per Indian Academy of Pediatrics (IAP) classification of PEM which is based on weight for age. Children whose weight is less than 80% of expected for age will be taken as cases (PEM group) and those whose weight is more than 80% of expected weight for age will be taken as controls.

Exclusion criteria:

1. Children suffering from endocrine disorders.

2. Children suffering from chronic infection like Tuberculosis.

3. Children suffering from malabsorption syndrome, protein losing nephropathy.

4. Children with congenital anomalies.

5. Children born preterm, children born with low birth weight.

Method of the study:

A total of 250 children aged 1 year to 5 years will be included in the present study after obtaining written informed consent from parents/guardian. They are divided into two groups of 125 each. Group 1 comprises of cases (PEM group) and group 2 comprises of controls. Details will be entered in predesigned proforma. Serum triiodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH), serum total protein and serum albumin estimation will be done in both PEM group (cases) and controls.

T3, T4, TSH levels will be estimated by Chemiluminescence method.

Serum total proteins level will be estimated by Biuret method, Serum albumin will be estimated by Bromocrisol green (BCG dye) method.

Statistical method used: Chi-square test, t-test, contingency coefficient analysis, descriptive statistics will be employed using Statistical Presentation Systems Software (SPSS) for windows version (16.0).

3. Does the study require any investigation/intervention to be conducted on patients / humans/ animals?

Yes. Serum thyroxine (T4), triiodothyronine (T3), thyroid stimulating hormone (TSH), serum total protein and albumin levels must be determined.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes

8. REFERNCES:

1. Global burden of protein-energy malnutrition in the year 2000; World Health Organization, Global Program on Evidence for Health Policy (GPE). Draft 15-08-06: page-1, ().

2. K E Elizabeth. Nutrition and Child Development 4th Edition; Paras 2010: 179-189.

3. Cicely D Williams. Kwashiorkor, The Lancet 16 November 1935; Volume 226, Issue 5855: 1151-52.

4. Rajul K Gupta, Rajvir Bhalwar. Text book on public health and community medicine 1st edition Department of Community Medicine AFMC Pune 2009;133:758-761.

5. International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Version for 2010. {}.

6. A Parthasarathy, Meenakshi N Mehta. IAP Textbook of Pediatrics 4th edition; Jaypee 2009: 138-42.

7. Fred Arnold, Sulabha Parasuraman, P. Arokiasamy, Monica Kothari. Nutrition in India, National Family Health Survey (NFHS-3) India 2005-06: 6-7.

8. P. Arokiasamy, Sunita Kishor, Rajeshri Chitanand, Bhawna Malik. National Family Health Survey (NFHS-3), India, 2005-06; Karnataka-published in September 2008:p19.

9. Pamela I. Brown and Jo Anne Brasel. Endocrine Changes in the Malnourished Child, Nestle Nutrition Workshop Series. Nestec Ltd. Vevey/Raven Press, Ltd. New York. 1990; Vol.19: 213-222.

10. Ingenbleek Y, Beckers C. Triiodothyronine and thyroid stimulating hormone in PCM in infants. Lancet 1975; November; volume 306, issue 7940: 845-848.

11. Farida Khatum UH, Khan M R, Ara F, Ahamed K, Choudhury S A. Study of thyroid functions in protein energy malnutrition. Bangladesh Med Res Counc Bull.1982 Dec; 8(2):68-71.

12. Onuora C, Maharajan G, Singh A, Etta K M.Thyroid status in various degrees of protein-calorie malnutrition in children. Clincal Endocrinolgy (oxf) 1983; Jan 18(1):87-93.

13. Turkay S, Gokalp A, Basin E, Onal A. Effects of protein energy malnutrition on circulating thyroid hormones. Indian Pediatrics 1995; 32: 193-196.

14. Orbak Z, Akin Y, Varoglu E, Tan H. Serum thyroid hormone and thyroid gland weight measurements in protein-energy malnutrition. Journal of Pediatric endocrinology & metabolism: JPEM 1998; Nov- Dec 11 (6): 719-24.

15. B K Das, B K Panda, Rajeev Dhingra, O P Mishra, J K Agarwal. Thyroid Hormone Studies in Protein-energy Malnutrition. Journal of Tropical Pediatrics 1999; vol.45 Dec: 375-76.

16. Pankaj Abrol, Ashok Verma, H.S Hooda. Thyroid hormone status in Protein energy malnutrition in Indian children. Indian Journal of Clinical Biochemistry 2001; 16(2):221-223.

17. Rahman M Z, Begum BA. Serum total protein,albumin and A/G ratio in different grades of protein energy malnutrition. Mymemsingh Med J 2005; Jan: 14(1):38-40.

18. Sanjeev Kumar, Jayashree Nandkarni, Rashmi Dwivedi. Thyroid Hormone status in Malnourished children. Indian Pediatrics 2009; volume 46-March 17: 263-264.

9. SIGNATURE OF THE CANDIDATE:

Dr SANDEEP M

10. REMARKS OF THE GUIDE:

11. NAME AND DESIGNATION OF

11.1 Guide: Dr VIJAY KUMAR B, MD, DCH

PROFESSOR,

DEPARTMENT OF PAEDIATRICS,

MYSORE MEDICAL COLLEGE

AND RESEARCH INSTITUTE,

MYSORE

11.2 SIGNATURE:

11.3 CO-GUIDE (IF ANY):

11.4 SIGNATURE:

11.5 HEAD OF THE DEPARTMENT: Dr B. KRISHNAMURTHY, MD, DCH

PROFESSOR AND HEAD,

DEPARTMENT OF PAEDIATRICS,

MYSORE MEDICAL COLLEGE

AND RESEARCH INSTITUTE,

MYSORE

11.6 SIGNATURE:

12 12.1 REMARKS OF DEAN

AND DIRECTOR:

12.2 SIGNATURE:

ETHICAL COMMITTEE CLEARANCE

1. TITLE OF DISSERTATION: THYROID HORMONE STATUS, SERUM TOTAL

PROTEIN, SERUM ALBUMIN LEVELS IN

CHILDREN WITH PROTEIN ENERGY

MALNUTRITION

2. NAME OF THE CANDIDATE: Dr SANDEEP M

3. SUBJECT: MD PAEDIATRICS

4. NAME OF THE GUIDE: Dr VIJAY KUMAR B, MD, DCH,

PROFESSOR,

DEPARTMENT OF PAEDIATRICS,

MYSORE MEDICAL COLLEGE

AND RESEARCH INSTITUTE,

MYSORE

5. NAME OF THE CO-GUIDE:

6. APPROVED/NOT APPROVED:

(If not approved, suggestions)

MEDICAL SUPERINTENDENT MEDICAL SUPERINTENDENT

K R HOSPITAL CHELUVAMBA HOSPITAL

MYSORE MYSORE

PROFESSOR AND HOD PROFESSOR AND HOD

DEPT OF MEDICINE DEPT OF SURGERY

MMC&RI, MYSORE MMC&RI, MYSORE

SUPERINTENDENT LAW EXPERT

PKTB HOSPITAL

MYSORE

DEAN AND DIRECTOR,

MMC&RI, MYSORE

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